Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Abstract

The clinical performance of biological therapies is affected by their manufacturing processes. The advent of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. This paper reviews important recently published technical data on adalimumab consistency and manufacturing experience from a clinical perspective, including the implications for immunogenicity when there are changes to a tightly controlled manufacturing process that may lead to variations in the epitopes of biological therapies.